Dr. Reddy's Laboratories has received regulatory approval from India's Drug Controller General of India (DCGI) to market semaglutide injection in the domestic market. This regulatory milestone marks an important development for the pharmaceutical company's product portfolio expansion in India.

Regulatory Approval Details

The DCGI approval enables Dr. Reddy's to commercially market semaglutide injection across India. This regulatory clearance follows the standard drug approval process overseen by India's central drug regulatory authority.

Strategic Significance

The approval represents Dr. Reddy's commitment to expanding its pharmaceutical offerings in the Indian market. Semaglutide injection adds to the company's existing therapeutic portfolio, demonstrating its focus on bringing important medications to Indian patients through proper regulatory channels.

This development aligns with Dr. Reddy's strategy of securing necessary regulatory approvals to strengthen its market position in India's pharmaceutical sector. The company continues to work through established regulatory frameworks to introduce new therapeutic options to the domestic market.

Dr Reddy's Laboratories is expected to face headwinds in the December quarter, with analysts projecting a challenging performance driven primarily by continued pressure from its US operations. The pharmaceutical major's consolidated results are anticipated to reflect the ongoing impact of reduced gRevlimid contribution and intensified pricing pressures in North America.

Financial Performance Outlook

Based on consensus estimates from five brokerages, Dr Reddy's financial performance for Q3 is expected to show significant pressure:

North America: gRevlimid Impact Dominates

The US business remains the primary concern for Dr Reddy's quarterly performance. Multiple brokerages have highlighted the significant challenges facing the North American operations:

YES Securities noted that Revlimid will no longer serve as a meaningful contributor after more than two years of sales, which exposes the underlying growth trajectory of the US base portfolio. The consensus among analysts indicates that pricing pressure and erosion in the base business will continue to weigh on the North American segment's performance.

India Business: Relative Strength

The domestic Indian market is expected to emerge as the strongest growth driver for Dr Reddy's in Q3. Analysts project robust performance across multiple therapeutic segments:

Analysts view the India business as structurally strong for Dr Reddy's, with differentiated product launches and chronic therapy portfolios continuing to gain market traction.

European Operations and Emerging Markets

Europe is anticipated to deliver steady growth momentum during the quarter. Kotak Equities expects particularly strong performance with 13% year-on-year growth, led by the nicotine replacement therapy portfolio. Axis Securities projects more modest but consistent 7% growth supported by steady demand and portfolio expansion.

For other international markets, brokerages forecast approximately 13% year-on-year growth, driven by stable emerging market demand. Kotak Equities specifically highlighted Russia's expected 15% year-on-year growth from volume expansion, though this may be partially offset by marginal rouble depreciation.

Key Development Areas

Beyond the quarterly financial performance, analysts will closely monitor several strategic developments that could influence Dr Reddy's medium-term growth trajectory. Progress on semaglutide approval in the Canadian market has been flagged by both Axis Securities and Motilal Oswal as an important growth visibility driver. Additionally, updates regarding Abatacept filing with the USFDA and potential US contract manufacturing partnerships will be closely watched, particularly in the context of mitigating tariff-related risks and strengthening the company's North American presence.